A new diabetes education program for the initiation of intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) was developed.

In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this programs will be tested.

MEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants)

Active Comparator: Current ICT program (ACC)

This education program consists of 10 lessons combining an insulin education program with an hypertension program

Behavioral: Current ICT program (ACC-ICT)

This program is conducted in 10 lessons in a group setting (4-8 participants)

Detailed Description:

The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help patients perform multiple-injection insulin therapy and adjust their insulin doses depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition, MEDIAS 2 ICT focuses on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.

The active comparator condition (ACC) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin and a hypertension education program for the treatment of hypertension. These education programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes and hypertension.

Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 lessons, which were conducted as group sessions.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

type 2 diabetes

age < 75 and age > 17 years

two years diabetes duration with oral treatment

BMI > 20 nad BMI < 40 kg/m²

informed consent

Exclusion Criteria:

current psychiatric disease

dementia or other severe cognitive impairment

severe complications

severe conditions (e.g., cancer)

gestational diabetes

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00901992